Sandra Michaelsen, Wobbeke Weistenhöfer, Rüdiger Bartsch, Nadine Hund, Gerlinde Schriever-Schwemmer, Hans Drexler, Andrea Hartwig
{"title":"Aluminium - Addendum: re-evaluation of the BAT Value and assignment to a pregnancy risk group: Assessment Values in Biological Material - Translation of the German version from 2025.","authors":"Sandra Michaelsen, Wobbeke Weistenhöfer, Rüdiger Bartsch, Nadine Hund, Gerlinde Schriever-Schwemmer, Hans Drexler, Andrea Hartwig","doi":"10.34865/bb742990e10_3ad","DOIUrl":"10.34865/bb742990e10_3ad","url":null,"abstract":"<p><p>The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) re-evaluated the data for aluminium [7429-90-5] to verify the biological tolerance value (BAT value) of 50 μg aluminium/g creatinine in urine and assign it to a pregnancy risk group. Relevant studies were identified from a literature search. In the previous evaluation, neurotoxic effects were considered the most sensitive systemic endpoint of aluminium and a BAT value of 50 μg aluminium/g creatinine was derived from a no observed adverse effect level (NOAEL) of 50 μg/g creatinine for the occurrence of preclinical neurotoxic effects in humans, which was determined by standardised neuropsychological test procedures in workplace studies. As the BAT value is thus well-founded and there are no more recent data that would call this into question, the BAT value for aluminium is confirmed. Sampling time is at the end of the shift, for long-term exposures after several previous shifts. There are no reliable studies available to assess the developmental toxicity and developmental neuroxicity of aluminium compounds in humans. There is no evidence that children are more sensitive to aluminium-induced neurotoxic effects than adults. In animal studies, aluminium concentrations in the urine of pregnant animals have not been determined and it is not known at which blood concentration developmental toxic or developmental neurotoxic effects occur in animals. There are also uncertainties regarding the transfer of animal data to humans. Therefore, a reliable risk assessment for developmental toxicity and developmental neurotoxicity is not possible and with regard to the BAT value of 50 µg aluminium/g creatinine, aluminium is assigned to Pregnancy Risk Group D.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 3","pages":"Doc053"},"PeriodicalIF":0.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12823117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146055852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael Bader, Bernd Roßbach, Thomas Göen, Elisabeth Eckert, Anja Schäferhenrich, Stefanie Nübler, Wolfgang Gries, Gabriele Leng, Jan Van Pul, Wolfgang Will, Andrea Hartwig
{"title":"Gas-chromatographic headspace analysis in human biomonitoring (headspace-gas chromatography): Biomonitoring Methods, Conceptual Topics - Translation of the German version from 2025.","authors":"Michael Bader, Bernd Roßbach, Thomas Göen, Elisabeth Eckert, Anja Schäferhenrich, Stefanie Nübler, Wolfgang Gries, Gabriele Leng, Jan Van Pul, Wolfgang Will, Andrea Hartwig","doi":"10.34865/bihsgcegt10_3or","DOIUrl":"10.34865/bihsgcegt10_3or","url":null,"abstract":"<p><p>The working group \"Analyses in Biological Materials\" of the German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) describes the current status of headspace-gas chromatography with respect to its potential applications in human biomonitoring. Particular focus is given to the review and discussion of newly developed methods for headspace sample collection as well as analyte enrichment. The article gives an overview on internationally published headspace methods for the matrices urine, blood, serum and plasma, existing assessment values for headspace parameters, background exposure levels in the non-occupationally exposed general population as well as half-lives of the most prominent hazardous substances measurable by headspace methods. In addition, critical requirements for and possible pitfalls of the preanalytical phase and of the calibration of headspace analyses are also discussed. The review shows that headspace methods have been continuously improved in recent decades and thus continue to make an important contribution to human biomonitoring of occupational and environmental exposure to volatile hazardous compounds.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 3","pages":"Doc057"},"PeriodicalIF":0.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12820732/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146055847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Aluminium und seine schwerlöslichen Verbindungen: MAK-Begründung, Nachtrag.","authors":"Andrea Hartwig","doi":"10.34865/mb742990verda10_3ad","DOIUrl":"10.34865/mb742990verda10_3ad","url":null,"abstract":"","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 3","pages":"Doc047"},"PeriodicalIF":0.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12823115/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146055812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Christian Monsé, George Dragan, Ulrich Prott, Christoph Emmel, Ralph Hebisch, Uta Lewin-Kretzschmar, Andrea Hartwig
{"title":"Nitrogen dioxide - Determination of nitrogen dioxide in the workplace air using ion chromatography (IC): Air Monitoring Method - Translation of the German version from 2025.","authors":"Christian Monsé, George Dragan, Ulrich Prott, Christoph Emmel, Ralph Hebisch, Uta Lewin-Kretzschmar, Andrea Hartwig","doi":"10.34865/am1010244e10_3or","DOIUrl":"https://doi.org/10.34865/am1010244e10_3or","url":null,"abstract":"<p><p>The working group \"Air Analyses\" of the German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) developed and verified the presented analytical method. It is used to determine the levels of nitrogen dioxide [10102-44-2] that occur in the workplace air. The method covers concentrations in the range from one tenth up to twice the current occupational exposure limit value (OELV) of 0.95 mg/m<sup>3</sup> (0.5 ml/m<sup>3</sup>). Samples are collected by drawing a defined volume of air through a sampling tube filled with aluminium oxide carrier material coated with triethanolamine (TEA) using a flow regulated pump at a volumetric flow rate of 1.8 l/min. The exposure during the shift is assessed with a sampling period of 2 hours and the short-term exposure with a period of 15 minutes. Nitrogen dioxide reacts with TEA with formation of TEA nitrite and TEA nitrate. Nitrite and nitrate are extracted with ultra-pure water and analysed by ion chromatography using conductivity detection. The quantitative determination is based on multiple-point calibrations with external standards. A relative limit of quantification (LOQ) of 0.009 mg/m<sup>3</sup> is obtained for an air sample volume of 216 litres. As the LOQ for a sample volume of 27 litres is well below 0.95 mg/m<sup>3</sup>, the short-term exposure limit (STEL; excursion factor 2) can also be measured. The mean recovery is 108% and the expanded uncertainty is below 28% for a sampling period of 2 hours.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 3","pages":"Doc055"},"PeriodicalIF":0.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12820727/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146055801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Aluminiumverbindungen, lösliche: MAK-Begründung.","authors":"Andrea Hartwig","doi":"10.34865/mb742990verdb10_3or","DOIUrl":"10.34865/mb742990verdb10_3or","url":null,"abstract":"","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 3","pages":"Doc048"},"PeriodicalIF":0.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12823120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146055770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Tetramethylol acetylenediurea: MAK Value Documentation - Translation of the German version from 2023.","authors":"Andrea Hartwig","doi":"10.34865/mb539550kske10_3or","DOIUrl":"10.34865/mb539550kske10_3or","url":null,"abstract":"<p><p>The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) has evaluated the data for tetramethylol acetylenediurea [5395-50-6] to derive an occupational exposure limit value (maximum concentration at the workplace, MAK value) considering all toxicological end points. Relevant studies were identified from a literature search and also unpublished study reports were used. Tetramethylol acetylenediurea releases formaldehyde in aqueous solution. Tetramethylol acetylenediurea is expected to occur in aerosol form because it has a very low vapour pressure. At a concentration of 21.7 mg/m<sup>3</sup> slight irritation in the larynx of rats occurs probably due to the impaction of the aerosol used in the study. Effects in the nasal cavity were observed at 96 mg/m<sup>3</sup> and above. Since 2014, the Commission has used an empirical approach for deriving MAK values for substances that induce effects on the upper respiratory tract as their critical effect. On this basis, the maximum concentration at the workplace (MAK value) has been set at 0.5 mg/m<sup>3</sup>. As the critical effect of tetramethylol acetylenediurea is irritation, Peak Limitation Category I has been assigned with an excursion factor of 2 in analogy to the classification made for formaldehyde. In rats, the NOAEL for developmental toxicity induced by tetramethylol acetylenediurea is 450 mg/kg body weight and the NOAEL for perinatal and parental toxicity is 1000 mg/kg body weight. As no teratogenicity was observed and the margins between the NOAELs and the MAK value are sufficiently large, tetramethylol acetylenediurea has been assigned to Pregnancy Risk Group C. Formaldehyde was classified in Carcinogen Category 4 because it causes nasal tumours at concentrations that exceed the detoxification capacity of that tissue. Studies investigating the carcinogenicity and germ cell mutagenicity of tetramethylol acetylenediurea are not available. Thus, in analogy to the classifications made for formaldehyde, the substance has been assigned to Carcinogen Category 4 and Germ Cell Mutagenicity Category 5. Clinical findings show sensitizing effects on the skin and tetramethylol acetylenediurea has therefore been designated with \"Sh\". There are no data for respiratory sensitization. Dermal absorption is not expected to contribute significantly to systemic toxicity.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 3","pages":"Doc051"},"PeriodicalIF":0.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12820712/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146055854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"<i>N</i>-Methylolchloracetamid: MAK-Begründung, Nachtrag.","authors":"Andrea Hartwig","doi":"10.34865/mb283219kskd10_2ad","DOIUrl":"10.34865/mb283219kskd10_2ad","url":null,"abstract":"","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 2","pages":"Doc024"},"PeriodicalIF":0.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12443134/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146047759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"1,1-Dichlorethen: MAK-Begründung, Nachtrag.","authors":"Andrea Hartwig","doi":"10.34865/mb7535d10_2ad","DOIUrl":"10.34865/mb7535d10_2ad","url":null,"abstract":"","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 2","pages":"Doc022"},"PeriodicalIF":0.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12443063/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146047734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"6-[(4-Methylphenyl)sulfonylamino]hexanoic acid: MAK Value Documentation - Translation of the German version from 2023.","authors":"Andrea Hartwig","doi":"10.34865/mb7852139kske10_2or","DOIUrl":"10.34865/mb7852139kske10_2or","url":null,"abstract":"<p><p>The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) has evaluated the occupational exposure limit value (maximum concentration at the workplace, MAK value) of 6-[(4-methylphenyl)sulfonylamino]hexanoic acid (<i>N</i>-tosyl-6-aminocaproic acid) [78521-39-8] considering all toxicological end points. Relevant studies were identified from a literature search and also unpublished study reports were used. The substance is a complexing agent. As the influence of the complexing effect and the acid effect on the respiratory tract is not known and inhalation studies are not available, a maximum concentration at the workplace (MAK value) cannot be derived. The NOAEL for developmental effects in rats after oral administration was 100 mg/kg body weight and day. In a gavage study in rats that was carried out according to OECD Test Guideline 422, pup mortality was increased and pup body weights were decreased up to postnatal day 4 at 1600 mg/kg body weight and day. The substance is not genotoxic in bacteria or mammalian cells. Carcinogenicity studies are not available. There is no evidence of a contact sensitizing potential. Skin contact is not expected to contribute significantly to systemic toxicity.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 2","pages":"Doc034"},"PeriodicalIF":0.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12443191/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146055996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Tetraethyllead and tetramethyllead - Addendum: re-evaluation of the BAT values and derivation of a BLW: Assessment Values in Biological Material - Translation of the German version from 2025.","authors":"Annette Greiner, Hans Drexler, Andrea Hartwig","doi":"10.34865/bb7800e10_2ad","DOIUrl":"10.34865/bb7800e10_2ad","url":null,"abstract":"<p><p>The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) re-evaluated the data for tetraethyllead [78-00-2] and tetramethyllead [75-74-1] considering all toxicological endpoints and derived a biological guidance value (BLW). Relevant studies were identified from a literature search. In 1994, the previous biological tolerance values (BAT values) for tetraethyllead and tetramethyllead were derived in correlation to the maximum workplace concentration (MAK value) of 50 µg as lead/m<sup>3</sup>. In 2023, the MAK value for organic lead compounds was lowered to 4 µg as lead/m<sup>3</sup>. There are no suitable studies for a corresponding reduction of the BAT value or the derivation of a specific BAT value for tetraethyllead. The former BAT values for tetraethyllead and tetramethyllead in urine are therefore withdrawn. Tetraethyllead is metabolised to triethyllead, diethyllead and inorganic lead. Tetramethyllead is metabolised to trimethyllead, dimethyllead and inorganic lead. Exposure to inorganic lead can best be measured via the blood lead concentration. For inorganic lead, a BAT value of 150 µg lead/l blood was derived in 2022. As organic lead compounds are more lipophilic and lead to more pronounced neurological effects than inorganic lead compounds, adverse effects cannot be excluded with certainty by compliance with the value of 150 µg lead/l blood, making a BAT value inapplicable. As a result, for tetraethyllead and tetramethyllead, a BLW of 150 µg lead/l blood is derived. Sampling time is not fixed in the steady state.</p>","PeriodicalId":521214,"journal":{"name":"The MAK collection for occupational health and safety","volume":"10 2","pages":"Doc039"},"PeriodicalIF":0.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12462664/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146055629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}